Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yen-Ko Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01476319
First received: August 1, 2011
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

This study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing patients in the emergency department (ED) about risks, benefits, and alternatives to receiving percutaneous cholecystostomy. Eligible patients will be approached when patients will be scheduled and waiting for receiving percutaneous cholecystostomy in the emergency department.


Condition Intervention
Cholecystitis
Other: video

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Resource links provided by NLM:


Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • knowledge and satisfaction measure [ Time Frame: immediately after intervention ] [ Designated as safety issue: No ]
    One questionnaire will be used as an outcome measure tool. Participants will be asked to complete one questionnaire with knowledge test and satisfaction evaluation with the process of informed consent after the educational sessions.


Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control Other: video
The intervention group includes patients who obtain information about percutaneous cholecystostomy from a video will view at their bedside on a laptop.
Experimental: video Other: video
The intervention group includes patients who obtain information about percutaneous cholecystostomy from a video will view at their bedside on a laptop.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients 18 years of age or older
  • scheduled to receive the percutaneous cholecystostomy

Exclusion Criteria:

  • clinically unstable
  • refuse to participate
  • are unable to understand the study process
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476319

Contacts
Contact: Yen-Ko Lin, MD 886-7-3121101 ext 7579 yenko@ms16.hinet.net

Locations
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Yen-Ko Lin, MD    886-7-3121101 ext 7579    yenko@ms16.hinet.net   
Sub-Investigator: Chia-Ju Lin, RN         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
  More Information

No publications provided

Responsible Party: Yen-Ko Lin, Attending Physician, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01476319     History of Changes
Other Study ID Numbers: KMUH-IRB-980360
Study First Received: August 1, 2011
Last Updated: November 17, 2011
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014